Kornimate/medical-research-clean huggingface dataset:
blood samples to identify biomarkers in haploidentical graft recipients

Conditions: Leukemia; Hodgkin Disease; Non-Hodgkin Lymphoma; Myelodysplastic Syndrome; Multiple Myeloma

Summary: the investigators are interested in identifying patient-specific factors related to donor chimerism in patients who receive nonmyeloablative hematopoietic stem cell transplants from haploidentical donors. we will look how patients' bodies break down and immediately respond to cyclophosphamide, fludarabine and mycophenolate mofetil.


Eligibility criteria:
inclusion criteria: * scheduled to receive nonmyeloablative conditioning which includes fludarabine * scheduled to receive a haploidentical graft * scheduled to receive postgrafting immunosuppression which includes oral mycophenolate mofetil (mmf) or enteric-coated mycophenolic acid * age \>18 years at the time of enrollment exclusion criteria: * diagnosed with an immunodeficiency disorder, including hiv

Keywords: hematopoietic stem cell transplantation cyclophosphamide fludarabine mycophenolate mofetil mycophenolic acid biomarkers
gender differences in prevalence of undiagnosed diabetes in acs

Conditions: Pre-diabetes; Diabetes

Summary: the primary goal of this study is to measure the prevalence of undiagnosed pre-diabetes/diabetes among women hospitalized with acute coronary syndromes (acs) compared to men. inpatients with confirmed acs (and no known prior history of diabetes) are invited to return to the yale hospital research unit 6-8 weeks after hospital discharge for an oral glucose tolerance test to identify individuals with pre-diabetes and diabetes.


Eligibility criteria:
inclusion criteria: * acute coronary syndrome * age \> 30 yrs exclusion criteria: * previously diagnosed diabetes * acs due to substance abuse or trauma

Keywords: undiagnosed diabetes undiagnosed pre-diabetes acute coronary syndrome undiagnosed pre-diabetes and undiagnosed diabetes
phase 2 study of adx-038 in complement-mediated kidney disease

Conditions: IgAN; C3G; Complement-mediated Kidney Disease

Summary: this phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (pk), and pharmacodynamics (pd) of adx-038 in adults with complement-mediated kidney diseases.


Eligibility criteria:
inclusion criteria: * mean egfr * clinical evidence of active kidney disease * been on supportive care * vaccine requirements * females must not be pregnant or breastfeeding * men must agree to use acceptable contraception and not donate sperm * igan: confirmed disease by kidney biopsy performed within 60 months prior to screening * c3g/ic-mpgn: confirmed disease by kidney biopsy performed within 18 months prior to screening exclusion criteria: * hereditary or acquired complement deficiency * kidney transplant or renal replacement therapy * history of solid organ transplant * other kidney disease * history of recurrent invasive infections * received complement inhibitor treatments * active systemic viral, bacterial, or fungal infection * liver dysfunction * no donating blood
preferential study

Conditions: Cataract Surgery; Glaucoma Surgery

Summary: to determine patient preference for the dexamethasone insert or topical prednisolone therapy through at day 45 as measured by - modified comtol survey.

eyes from 80 patients will be randomized in a 1:1 ratio to the assigned treatment, dexamethasone insert placed at the time of surgery, or topical prednisolone acetate 1% therapy prescribed on a tapering dose schedule post-operatively. males and females 18 years and older with 1)presence of a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens (iol), and potential postoperative snellen pinhole corrected distance visual acuity (cdva) of at least 20/200 in both eyes and 2) 10 patients with mild-to-moderate primary open angle glaucoma and a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular len (iol) combined with a minimally invasive glaucoma surgery (migs) procedure in both eyes. study visits will consist of eye exam with ocular photos from an optical coherence tomography (oct).

Eligibility criteria:
inclusion criteria: * age 18 years and older * presence of a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens (iol), and potential postoperative snellen pinhole cdva of at least 20/200 in both eyes * 10 patients with mild-to-moderate primary open angle glaucoma and a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber iol combined with a minimally invasive glaucoma surgery (migs) procedure in both eyes exclusion criteria: * active or history of chronic or recurrent inflammatory eye disease in either eye * ocular pain in either eye * proliferative diabetic retinopathy in either eye * significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye * laser or incisional ocular surgery during the study period and 6 months prior in either eye * systemic concomitant pain medication management with pharmacologic class of oxycodone * systemic nsaid use o pre-procedural wash-out period for topical nsaids, ocular steroid, cyclosporine of 7 days * clinically significant macular edema (csme) * history of cystoid macular edema in the study eye
a study of baricitinib (ly3009104) in adults with severe or very severe alopecia areata

Conditions: Alopecia Areata

Summary: the reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (aa).


Eligibility criteria:
inclusion criteria: * are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent. * have severe or very severe aa, as determined by all of the following: * current aa episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured by salt (aa-iga of 3 or 4) at screening and baseline. * no spontaneous improvement over the past 6 months. * current episode of severe or very severe aa of less than 8 years. note: participants who have severe or very severe aa for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years. * male or nonpregnant, nonbreastfeeding female participants. exclusion criteria: * primarily "diffuse" type of aa. * are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on aa. * previously treated with an oral janus kinase (jak) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment).
study to evaluate potential decrease in hospitalization events, time between events, and increasing longevity in patients with symptomatic heart failure (0954-948)

Conditions: Heart Failure

Summary: this is a multicenter study to evaluate potential decrease in hospitalization events and time between events and increasing longevity in patients with symptomatic congestive heart failure and intolerant of first-line medication for heart failure. this study will evaluate if higher doses of the investigational drug given daily will be superior to the lower dose of the same investigational drug given daily.


Eligibility criteria:
inclusion criteria: * symptomatic heart failure with known or recently diagnosed intolerance of treatment with first-line medication for heart failure * may or may not be receiving an alternative and/or additional drug treatment
primary prevention study: study on obesity, cardiovascular and psycho-social characteristics in the city of merzig

Conditions: Obesity; Cardiovascular Disease; Depression; Stress

Summary: cardiovascular risk factors and psycho-social characteristics will be determined in obese and non-obese patients in the setting of primary medical care.

cardiovascular risk factors and psycho-social characteristics will be determined using a questionnaire in primary care physician offices in the city of merzig, germany. we will recruit all people (age\>18y) with a body-mass index (bmi) \> 30 kg/m2 plus patients in the two following participating physician offices: praxisnetz and merzig. cardiovascular risk will be assessed using the procam (munster heart study), esc (european society of cardiology) and framingham risk scores. psycho-social factors will be recorded according to the methodology of the interheart study.

Eligibility criteria:
inclusion criteria: * age 18 or \> 18 * bmi \> 30 kg/m2 * presenting to a participating primary care physician exclusion criteria: * age \< 18

Keywords: obesity cardiovascular disease depression stress
evaluation of an online lifestyle intervention in mexican school children during covid-19 pandemic

Conditions: Childhood Obesity

Summary: introduction: school closures due to the covid-19 pandemic represent a risk factor for the development of childhood obesity due to the increase in unhealthy behaviors. online lifestyle interventions in schoolchildren could help to mitigate this problem. however, to date, no randomized controlled trials have been performed to prevent obesity in schoolchildren during the covid-19 pandemic. the aim of this study is to evaluate the effect of a 4-month online lifestyle intervention on the bmi z-score of mexican schoolchildren during the covid-19 pandemic in an intervention group compared to a control group. methodology: this is a pilot randomized controlled trial. schoolchildren from a public elementary school in hermosillo, sonora, mexico will be invited to participate. participants will be randomized to an intervention group (online lifestyle intervention) or a control group. the intervention will include online sessions of nutrition education and physical activity and nutrition information for parents. the control group will receive a digital brochure with nutrition recommendations at the beginning of the study. the measurements will be performed at baseline and 4 months. the primary outcome will be the bmi z- score. secondary outcomes: waist circumference, fat percentage, nutritional knowledge, lifestyle parameters, retention, attendance at the program sessions, and acceptability of the intervention. the difference between groups in changes in the outcomes will be analyzed using an intention to treat analysis. the protocol was approved by the research ethics committee of the university of sonora nursing department (epm-003-2020). conclusion: the study will provide the first evidence of the evaluation of online interventions for the prevention of obesity in schoolchildren derived from a randomized controlled trial. this information will be important for the development and implementation of other school-level obesity prevention programs around the world.


Eligibility criteria:
inclusion criteria: * 4th, 5th and 6th- grade students from the participating primary school. * have access to the internet. * have an electronic device (e.g. computer, laptop, tablet, or smart cell phone). * nutritional status: normal weight, overweight, or obesity (based on bmi-z-score for age). exclusion criteria: * have a medical condition that affects body weight. * takes medicine that affects body weight. * participating in another intervention that affects body weight. * have a condition that prevents physical activity. * withdrawal of informed consent or assent. * have a family member who is participating in the study.

Keywords: online lifestyle intervention prevention childhood obesity nutrition education physical activity covid-19
prospective monocentric study on the efficacy of lidocain spray for patient comfort during nasogastric tube insertion in enteral nutrition

Conditions: Undernutrition

Summary: enteral nutrition is the treatment of choice for malnourish patient. nasogastric tube (ngt) is although a common act. unfortunately, this procedure can be painful. also, many patients will need many ngt re-insertion. therefore, the investigators need to increase the acceptability of this procedure by increasing comfort during ngt passage. professionals guidelines of has (recommendations professionnelles de bonne pratiques de soins) and sfnep (société française de nutrition clinique et métabolisme) talk about the possibility of using local anesthesic without ordering their use. however, ngt tube insertion is often put without pre-medication in the face of an accumulating body of evidence indicating that local anesthetic prior ngt insertion decrease discomfort of the procedure. on the other hand, these studies have been done in the emergency room with ngt of a bigger gauge and for many reasons except enteral nutrition. the investigators primary objective of this prospective monocentric study is to evaluate the efficacy (patient comfort) of lidocaine 5 % spray versus placebo (physiologic serum) before ngt insertion in patient needing enteral nutrition, using visual analogue scale. secondary objectives are to evaluate nurse and patient satisfaction using questionnaires, facility of ngt insertion using likert scale, numbers of try, time of procedure, complications like tracheal insertion and success of the insertion using thorax x-ray. the study will be held in chu nice at nutrition unit support. after signed consentment, patients will be separate in two groups : group a (lidocaïne spray 5 %) and group b (physiologic serum). there will be 2 spray in nostril and 2 in orophagyngeal cavity 2 minutes before ngt insertion, which will be done by a competent nurse. vital signs will be noted at the beginning of the procedure and 10 minutes after. at the end, the nurse and the patient will have to answer a questionnaire. pain will be grade using visual analogue scale immediately after the procedure. demographic data and complications will be note by the investigator. finally, thorax x-ray will be done at the end of the procedure. there will be 34 patients by group. if the investigators find a benefit, this can change their practice and guidelines.


Eligibility criteria:
inclusion criteria: * \> 18 years * patient needing enteral nutrition by ngt * signed consentment * affiliation to securite sociale exclusion criteria * lidocaine allergy * severe demencia * non cooperating patient * facial trauma and basal skull fracture * reflex deglutition problem * pulmonary illness like severe asthma * hemodynamic instability * pregnancy and nursing * patient on guardianship
follow-up of bariatric surgery by teleconsultations

Conditions: Obesity

Summary: an organised follow-up is required after bariatric surgery, but 50% of patients are lost to follow-up after 2 years. to design a large randomized clinical trial (rct) comparing teleevaluations and teleconsultations to classical follow, aiming to prove that the quality of the follow-up is maintained and the patient-experience is improved, at a lower cost in people living far from the reference centre, this pilot study aims at describing the distribution of the collected criteria.

an organised follow-up is required after bariatric surgery, but 50% of patients are lost to follow-up after 2 years. this follow-up requires about 5 multi-professional evaluations during the first year. this can be cumbersome in patients living far from the reference centre and who may perceive the necessary time, cost and lost of income, and constraints as imbalanced. teleevaluations and teleconsultations may solve this issue by replacing some of the classical evaluations (at 6 and 9 months). an rct would be necessary, and a pilot study is proposed to describe the distribution of the judgment criteria. this pilot study aims at describing all the parameters necessary to build an rct, and involves the randomisation of operated patients recruited 3 months after surgery, in to groups. one will have the classical follow-up (venue and consultations at 6 and 9 months) the over will have teleevaluations and teleconsultations ; the parameters will be described at 12 months. the teleevaluation is either proposed as usual (a file is sent by secure mail) or by chatbot interaction. the consultation and the teleconsultation are based on the standard of care scenario.

Eligibility criteria:
inclusion criteria: * adults having had bariatric surgery 3 months before * able to use an internet tool of chatbot and skype-like secured connection * adult under 60 years old * free inform and sign consent * living more than 50km from toulouse * persons with social security exclusion criteria: * complications at the 3rd month post-surgery requiring specific care * insufficient internet connection * minor * pregnant women * protected adults * people in emergency * people unable to give consent

Keywords: bariatric surgery follow-up tele-evaluations e-medicine
intervention-induced plasticity of flexibility and learning mechanisms in asd

Conditions: Executive Dysfunction; Autism Spectrum Disorder; Adolescent Behavior

Summary: this project explores the association between learning and cognitive flexibility by testing whether a cognitive behavioral intervention designed to improve flexibility in asd changes learning and associated neural activation using model-based functional magnetic resonance imaging (m-fmri). the study proposes that variability in learning mechanisms is associated with behavioral flexibility and explains differences in adaptive and treatment outcomes. the study employs a longitudinal case-controlled design in 60 14-18 year old youth with asd at 3 time-points 8 months apart, each including m-fmri during learning and behavioral measurement of executive and adaptive function. aim 1 tests the hypothesis that individual variation in learning biases and their neural correlates predicts behavioral flexibility and is stable over time. aim 2 tests plasticity of learning mechanisms induced by a cognitive-behavioral intervention for flexibility. aim 3 tests hypothesis about intervention-induced plasticity of neural functional connectivity.


Eligibility criteria:
inclusion criteria: 1. 14-18 years of age inclusive 2. full scale iq \> 80 on a standardized iq test, either confirmed through educational testing within the last two years or confirmed by the wechsler abbreviated scale of intelligence (wasi-2) administered by research personnel. if current iq testing (fsiq) is not interpretable based on discrepancies between verbal and perceptual skills, we will use the best available verbal iq estimate. 3. broad asd diagnosis according to diagnostic statistical manual, fifth edition (dsm-5) criteria established by parent report of prior clinical diagnosis and confirmed by meeting cutoff criteria on the social communication questionnaire (i.e., raw score \> 11) or the autism diagnostic observation schedule-2 (ados-2), module 4 (total score ≥7). 4. intact or corrected hearing and vision. 5. parents/guardians speak and read english with sufficient fluency for completion of consent forms and informant questionnaires; youth participants will use/understand english as a primary or secondary language with sufficient fluency to engage effectively in executive function group therapy conducted in english, and for valid administration of neuropsychological and behavioral measures. exclusion criteria: 1. presence of a known medical condition in the participant that would interfere with his/her ability to participate in the study. 2. to preserve the integrity of the neuroimaging data, participants will be excluded if they have a history of neurological disorder, such as an established epilepsy diagnosis, significant brain trauma, hydrocephalus, central nervous system infection, or stroke. 3. contraindications for mri such as metal implants, dental braces, pregnancy (determined by parent or self-report).

Keywords: autism spectrum disorder executive function intervention mri scanning neuroimaging learning mechanisms
autonomic dysfunction in patients with migraine: cardiovascular and neurophysiology assessment

Conditions: Migraine Headache

Summary: autonomic dysfunction in patients with migraine: cardiovascular and neurophysiology assessment.

assessment if autonomic dysfunction in patients with migraine by using cardiovascular assessment by hotler monitoring and table tilt test and neurophysiology assessment by sympathetic skin response

Eligibility criteria:
inclusion criteria: * 1.fulfilling ichd-3 criteria for migraine 2. migraine for at least 3 months. exclusion criteria: brain imaging showing structural brain lesions. .medications that could impact autonomic function such as tricyclic antidepressants, anticholinergics, or opioids. * patients with concomitant medical illness causing autonomic dysfunction such as: diabetes, cardiovascular, demyelinating or degenerative neurological disorders. * contraindications for performing the tilt test * pregnant patients.
efficacy and safety of tak-385 in the treatment of uterine fibroids

Conditions: Uterine Fibroids

Summary: the purpose of this study is to determine the efficacy and safety of tak-385, once daily (qd), for 12 weeks in women with uterine fibroids.

this study is a phase ii, multicenter, randomized, double-blind, parallel-group, placebo-controlled for evaluation of the efficacy and safety of tak-385 10, 20, and 40 mg (p.o.) following once daily administration for 12 weeks in women with uterine fibroids.

Eligibility criteria:
inclusion criteria: 1. the participant has been diagnosed with uterine fibroids and has never received surgical treatment for the myoma. 2. the participant is a premenopausal woman. 3. the participant has one or more measurable noncalcified myomas confirmed by transvaginal sonography. 4. the participant has experienced regular menstrual cycles 5. the participant is diagnosed as menorrhagia exclusion criteria: 1. participants with a screening hb \<8 g/dl 2. participants with a previous or current history of blood disorders 3. participants with a known history of severe hypersensitivity or severe allergy to sanitary goods 4. participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis 5. participants with a previous or current history of thyroid dysfunction 6. participants with a previous or current history of pelvic inflammatory disease 7. participants with a positive pap smear test result 8. participants with a history of panhysterectomy or bilateral oophorectomy 9. participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding 10. participants with a previous or current history of a malignant tumor 11. participants who have been treated with any of the following drugs: anticoagulant drug, antiplatelet drug, tranexamic acid, selective estrogen receptor modulator (serm), activated vitamin d, other vitamin d, calcitonin, ipriflavone, steroid hormone, vitamin k, teriparatide, or denosumab 12. participants who have been treated with any of the following drugs: oral contraceptive and sex hormone preparation, gonadotropin-releasing hormone (gnrh) analogue, dienogest, danazol, or aromatase inhibitor 13. participants who have been treated with a bisphosphonate preparation 14. participants with a previous or current history of severe hypersensitivity or severe allergy to drugs 15. participants with non-diagnosable abnormal genital bleeding 16. participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases 17. participants with clinically significant cardiovascular disease or uncontrollable hypertension 18. participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ecg) findings 19. participants with active liver disease or jaundice, or with alanine aminotransferase (alt), aspartate aminotransferase (ast), or total bilirubin \> 1.5 times the upper limit of normal (uln)

Keywords: drug therapy